The Medicines Company reported a presentation of a pooled analysis of 5,800 patients in the EUROMAX and HORIZONS AMI trials, two international clinical trials comparing Angiomax (bivalirudin) versus heparin with or without glycoprotein IIb/IIIa inhibitors (GP IIb/IIIa) in patients with ST-segment elevation acute myocardial infarction (STEMI) undergoing percutaneous coronary intervention. EUROMAX and HORIZONS AMI studies were presented and published individually in September 2008 and October 2013, in The Lancet and The New England Journal of Medicine respectively.
Lead author, presenter and primary investigator of the EUROMAX trial P Gabriel Steg, of Hôpital Bichat in Paris, France, says, “The totality of the findings in this analysis confirm the earlier findings of the EUROMAX and HORIZONS-AMI trials, and support the fact that bivalirudin should remain the preferred anticoagulant of choice for clinicians treating STEMI patients undergoing primary percutaneous coronary intervention.”
The totality of the data in the EUROMAX and HORIZONS-AMI trials of 5,800 STEMI patients undergoing primary percutaneous coronary intervention showed a significant absolute reduction in cardiac death of 0.9% (2.0% for bivalirudin vs. 2.9% for control; OR 0.70, 95% CI 0.50-0.97, p=0.03); absolute reduction in major non-CABG-related bleeding of 3.6% (4.2% for bivalirudin vs. 7.8% for control; OR 0.53, 95% CI 0.43-0.66, p=<0.0001); absolute reduction in transfusion of 1.7% (2.1% for bivalirudin vs. 3.8% for control; OR 0.57, 95% CI 0.42-0.77, p=0.0002); and absolute reduction in net adverse clinical events (NACE) of 3.1% (8.8% for bivalirudin vs. 11.9% for control; OR 0.74, 95% CI 0.63-0.86, p=<0.0001). The analysis also showed an increased risk of stent thrombosis, driven by an increase in acute stent thrombosis absolute risk of 1.0% (1.2% for bivalirudin vs. 0.2% for control; OR 6.04, 95% CI 2.55-14.31, p=<0.0001). The findings were consistent across all examined subgroups.
“As we had seen in the results of the EUROMAX and HORIZONS-AMI trials when they were first presented and published, this analysis underscores that use of bivalirudin, compared with a combination of heparin and a GP IIb/IIIa inhibitor, is associated with significant absolute reductions in risk for cardiac death and major non-CABG bleeding,” says Gregg W Stone, professor of medicine at Columbia University College of Physicians and Surgeons, director of Cardiovascular Research and Education at the Center for Interventional Vascular Therapy at New York-Presbyterian Hospital/Columbia University Medical Center and co-director of the Medical Research and Education Division at the Cardiovascular Research Foundation. Stone is the principal investigator of the HORIZONS-AMI trial.